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Guide Wire（Zebra）
EUDAMEDClass IIa (EU MDR)
Ref 06936345105671Model ZSR-GS、ZSR-GM
Identity
- Trade Name
- Guide Wire（Zebra） EUDAMED
- Model / Reference
- ZSR-GS、ZSR-GM EUDAMED06936345105671 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936345105671 EUDAMED
- Basic UDI-DI
- 69363451ZSRGWZ005CU EUDAMED
- EMDN Code
- U0602 UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Guide Wire（Zebra） by Dongguan ZSR Biomedical Technology Company Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69363451ZSRGWZ005CU | Class IIa | Active |
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Manufacturer
- Manufacturer
- Dongguan ZSR Biomedical Technology Company Limited
- EUDAMED SRN
- CN-MF-000016828
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 86c1e557-30a8-46ae-b7e9-1a92c13db19a 61 fields · synced Jun 18, 2026